SGLT2i and Incretin and CRTd.

NCT03282136 — Phase 4, Completed, 500 participants, University of Campania Luigi Vanvitelli

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Incretin Treatment and Combined to SGLT2i Effect in Type 2 Diabetes Mellitus Patients Affected by Heart Failure With Depressed Ejection Fraction, and Treated by Cardiac Resynchronization Therapy With a Defibrillator.

Registry	NCT03282136
Status	Completed
Phase	Phase 4
Study type	Interventional; randomized, parallel, masking: single, treatment
Enrollment	500 (Actual)
Sponsor	University of Campania Luigi Vanvitelli (Other)
Conditions	Type 2 Diabetes Mellitus, Heart Failure
Interventions	Incretin Effect, Cardiac Resynchronization therapy defibrillator device, SGLT-2 inhibitor (Drug, device)
Dates	start 2017-09-01, primary completion 2024-09-01, completion 2024-09-01, first posted 2017-09-13, last updated 2025-06-25
Locations	1 site in Italy

-Summary

Incretin therapy and sodium-glucose- transporter2 inhibitors (SGLT2i) are a treatment for type 2 diabetes (T2DM) affected by heart failure (HF) and treated with cardiac resynchromization therapy (CRT). In this study the investigators will recruit T2DM patients affected by HF with depressed ejection fraction and treated by CRT. These patients will randomly be treated by incretin v/s SGLT2i vs combined therapy with incretin+SGLT2i (and added to conventional hypoglicemic drugs). In these patients investigators will report at follow up CRT-d responders rate, mortality, and hospital admission for HF worsening. Combined therapy with incretin and SGLT2i may reduce hospital admissions for HF in T2DM v/s incretin and/or SGLT2i therapy (added to conventional hypoglicemic drugs).

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+Arms and interventions

Arm	Type	Interventions	Description
incretin arm	Active comparator	Drug: Incretin Effect; Device: Cardiac Resynchronization therapy defibrillator device	T2DM with HF treated by CRTd participants will be assigned prospectively to an intervention (incretin therapy plus conventional hypoglycemic drug therapy) according to study protocol to evaluate the effect of the drug on cardiac deaths, all cause deaths, and hospital admission for heart failure.
conventional hypoglycemic drug arm	Placebo comparator	Device: Cardiac Resynchronization therapy defibrillator device	T2DM with HF treated by CRTd participants will be assigned prospectively to SGLT2i therapy (plus conventional hypoglycemic drug therapy) according to study protocol to evaluate the effect of the drug on cardiac deaths, all cause deaths, and hospital admission for heart failure.
Incretin added to SGLT2i	Active comparator	Drug: SGLT-2 inhibitor	T2DM with HF treated by CRTd participants will be assigned prospectively to SGLT2i added to incretin therapy (plus conventional hypoglycemic drug therapy) according to study protocol to evaluate the effect of the drug on cardiac deaths, all cause deaths, and hospital admission for heart failure.

Incretin Effect (Drug): The patients will receive incretins therapy.
Cardiac Resynchronization therapy defibrillator device (Device): The patients will receive a Cardiac Resynchronization therapy defibrillator device
SGLT-2 inhibitor (Drug): The patients will receive SGLT2i therapy.

+Outcome measures

Primary outcomes

all cause mortality, and cardiac cause mortality. [12 months]
CRT responders [12 months]

Secondary outcomes

hospital admissions for HF [12 months]

+Eligibility

Sex: All, ages: 18 Years to 70 Years

Inclusion Criteria:

* aged more than 18 years, with clinical hystory of T2DM non insulin dependent, and diagnosed failing heart with depressed ejection fraction; CRTd recipients.

Exclusion Criteria:

* T2DM in insuline therapy; renal impairment, chronic inflammatory and systemic diseases; neoplastic diseases.

+Locations (1)

Facility	City	Country	Status
Raffaele Marfella	Naples, Italy	Italy

+Publications

Results publication: Sardu C, Paolisso P, Sacra C, Santamaria M, de Lucia C, Ruocco A, Mauro C, Paolisso G, Rizzo MR, Barbieri M, Marfella R. Cardiac resynchronization therapy with a defibrillator (CRTd) in failing heart patients with type 2 diabetes mellitus and treated by glucagon-like peptide 1 receptor agonists (GLP-1 RA) therapy vs. conventional hypoglycemic drugs: arrhythmic burden, hospitalizations for heart failure, and CRTd responders rate. Cardiovasc Diabetol. 2018 Oct 22;17(1):137. doi: 10.1186/s12933-018-0778-9. PMID 30348145

My Notes

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